Equipment Validation Supervisor

Job Title:

Equipment Validation Supervisor

Location:

Bedford, Ohio

Job Type: Full-Time

Hikma Pharmaceuticals USA Inc. is a developer, manufacturer, and supplier of essential medicines, committed to bringing better health to millions worldwide. With 32 manufacturing plants, eight R&D centers, and 9,500+ employees, we provide high‑quality generic, specialty, and branded products across the globe.

We are seeking a talented and motivated Equipment Validation Supervisor to lead qualification and validation activities for sterile and injectable manufacturing environments, ensuring compliance with FDA, cGMP, and global regulatory standards.

• Lead, coach, and develop a team of validation engineers/specialists.
• Allocate resources and manage validation priorities aligned with production and project timelines.
• Foster a culture of compliance, quality, and continuous improvement.

• Oversee and approve execution of:
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
• Ensure validation of critical GMP equipment
  , including:
  • Filling lines, autoclaves, lyophilizers, sterilizers
  • HVAC systems and cleanroom equipment
  • Packaging and inspection systems
• Ensure compliance with Annex 1 (sterile manufacturing) where applicable.

• Ensure all validation activities comply with:
  • FDA (21 CFR Part 210/211)
  • EU GMP / Annex 1
  • ICH guidelines
• Maintain inspection readiness for FDA, MHRA, and other global regulatory audits.
• Review and approve validation protocols, reports, SOPs, and change controls.

• Lead validation efforts for:
  • New equipment and facility expansions
  • Technology transfers and new product launches
• Manage equipment lifecycle, including periodic review and requalification
  .
• Collaborate with Engineering and Manufacturing on commissioning and qualification (C&Q).

• Oversee investigations related to validation failures or deviations.
• Lead root cause analysis and ensure timely implementation of CAPA.
• Conduct risk assessments using tools like FMEA and support risk‑based validation strategies.

• Partner with QA, Engineering, MS&T, Regulatory Affairs, and Operations teams.
• Support process improvements and operational efficiency initiatives.
• Provide technical expertise during audits, inspections, and regulatory submissions.

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, or related discipline
• Master’s degree preferred

• 5+ years of experience in pharmaceutical validation, preferably in sterile/injectable manufacturing
• Minimum 1 year in a supervisory or leadership role
• Experience working in FDA‑inspected facilities

• Deep knowledge of validation lifecycle (IQ/OQ/PQ) and risk‑based validation approaches
• Strong experience with aseptic processing and sterile equipment validation
• Familiarity with:
  • GAMP 5 (for computerized systems)
  • Cleaning validation and process validation (preferred)
• Understanding of calibration, maintenance, and asset lifecycle systems

• Strong leadership and team development skills
• Excellent communication and stakeholder management
• High attention to detail and strong documentation skills
• Ability to manage multiple priorities in a fast‑paced GMP environment

• Experience in injectables or high‑volume generics manufacturing
• Lean Six Sigma certification
• Experience with electronic validation systems and QMS platforms (e.g., Track Wise, Veeva)

Base Salary: $59,900.00 to $ annually. Compensation will be determined during the interview process and will vary based on factors such as location, experience, and market.

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma‑sponsored 401(k) program at a pre‑tax contribution rate of 4% of eligible pay. Hikma will match…